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    Regulatory Specialist - Scarborough, United States - INTELLECTT INC

    INTELLECTT INC
    INTELLECTT INC Scarborough, United States

    4 weeks ago

    Intellectt Inc background
    Description

    Role :
    Regulatory Specialist IILocation : Scarborough, ME Duration : 06+ Months on W2 (Contract only)

    Shift Timings : 8 am - 5 pm

    Skills Looking For:

    • The project entails a regulatory affairs specialist position focusing on IVDR compliance for European regulations.
    • Strong IVDR (In Vitro Diagnostic Regulation) experience is required.
    • Regulatory affairs expertise, ideally with four plus years of experience.
    • Familiarity with European regulations and strong technical writing skills.
    Day-to-day Responsibilities: Compiling and submitting regulatory documents to health authorities; Interacting with various departments for document compilation and submission; Independent work on regulatory tasks while also collaborating cross-functionally.
    • Candidates seeking a project management role overseeing the entire regulatory process may be considered overqualified.

    Education and Level of Experience:

    • Bachelor's degree required, preferably with a background in biology, chemistry, or a related scientific field.
    • Four plus years of regulatory affairs experience, with specific emphasis on IVDR. 2 to 3 years of IVDR regulatory experience is also fine but must have an overall 4 years of regulatory experience.

    Top 3 Skills:

    • Strong IVDR experience
    • Regulatory affairs expertise
    • Independent yet collaborative work approach

    Interview Process:

    • 2 to 3 rounds of interviews.
    • First round will be onsite with the manager and next two rounds will be virtual with other team members.#J-18808-Ljbffr
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